A Clincal Study of Max-40279-01 in Patients With Advanced Colorectal Cancer
NCT ID: NCT05130021
Last Updated: 2021-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
130 participants
INTERVENTIONAL
2022-01-31
2023-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Part 1;50mg
MAX-40279-01
MAX-40279-01 50mg/70mg
Part 1;70mg
MAX-40279-01
MAX-40279-01 50mg/70mg
Part 2;MAX-40279-01
MAX-40279-01
MAX-40279-01 50mg/70mg
Part 2;regorafenib
regorafenib
regorafenib
Interventions
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MAX-40279-01
MAX-40279-01 50mg/70mg
regorafenib
regorafenib
Eligibility Criteria
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Inclusion Criteria
2. Histologically and/or cytologically documented local advanced or metastatic colorectal adenocarcinoma.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
4. Expected survival \>3 months.
5. previously treated with standard, approved therapies, including two lines of chemotherapy (fluoropyrimidine,oxaliplatin and irinotecan based), a biological VEGF inhibitor, and, if RAS wild-type, an EGFR inhibitor. Patients with MSI-H/MMR-deficient tumors also must have received an immune checkpoint inhibitor, if available and approved. In addition, patients with BRAF mutant tumors must also have received a BRAF inhibitor, if available and approved.
6. Signed informed consent form.
Exclusion Criteria
3. Inadequate organ or bone marrow function.
4. Medical history of difficulty swallowing, malabsorption or other chronic gastrointestinal disease, or conditions that may hamper compliance and/or absorption of the tested product.
5. Pregnant or breast-feeding woman.
6. Known allergies, hypersensitivity, or intolerance to Max-40279-01 the excipients of these treatments The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
18 Years
ALL
No
Sponsors
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Maxinovel Pty., Ltd.
INDUSTRY
Responsible Party
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Locations
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The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Yanhong Deng, Dr
Role: primary
Other Identifiers
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MAX-40279-005
Identifier Type: -
Identifier Source: org_study_id